OBJECTIVETo determine the effects of multifactorial inspiratory muscle training (IMT) combined with Otago Exercise Programme (OEP) on balance and quality of life (QoL) in patients with diabetes.METHODSPretest-post-test randomised controlled trial.SETTINGRehabilitation Department of Pakistan Railway General Hospital.PARTICIPANTS70 patients with diabetes were randomly assigned to experimental or placebo groups, out of which 59 patients completed the intervention.INTERVENTIONPatients in the experimental group performed OEP+IMT (at 50% of baseline maximum inspiratory pressure (MIP)) whereas the placebo group performed OEP+sham IMT (at 15% of MIP). Both groups exercised for 12 consecutive weeks.OUTCOME MEASURESOutcome measures included nine variables: the Berg Balance Scale (BBS), the Biodex Postural Stability System (including postural stability test (Overall Stability Index, Anterior-Posterior Index and Mediolateral Index), fall risk test (FRT), Limits of Stability (LOS) test (time to complete test and direction control), Clinical Test of Sensory Interaction and Balance (CTSIB)) and the Audit of Diabetes Dependent Quality of Life questionnaire.RESULTSOut of 59 patients who completed treatment, 37.1% were men and 62.9% were women with a mean age of 58.37±5.91 years. Results show significant interaction effects on BBS scores with the mean score improving from 41.87±2.61 to 49.16±2.50 in IMT versus sham IMT group with scores improving from 41.58±2.51 to 45.74±2.30. The IMT group significantly improved in dynamic balance tested through BBS (p=0.003), anticipatory balance through LOS test (p=0.003), reactive balance tested through FRT (p=0.04), direction control (p=0.03) and sensory integration through CTSIB test (p=0.04) when compared with the sham IMT group. While no significant changes (p>0.05) between groups were observed in QoL and static balance; significant changes (p<0.05) within group were observed in both groups in QoL and static balance.CONCLUSIONAdditional research is necessary to understand the association between inspiratory muscle strength and balance, however, we demonstrated that a multifactorial IMT intervention should be used with patients with diabetes to improve balance, postural control and reduce fall risks.TRIAL REGISTRATION NUMBERClinicalTrials.gov, NCT#04947163.